We Assist Companies and Practices of All Sizes with All Aspects of Compliance
Compliance Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
In today’s world, compliance is a necessity. Establishing and maintaining an effective compliance program is just part of doing business, and companies and practices in all industries need to take adequate steps to ensure that they are meeting their legal and regulatory obligations.
For most, this is easier said than done.
Companies’ and practices’ compliance obligations are becoming increasingly complex. They are also changing constantly. What is sufficient today won’t necessarily be sufficient tomorrow. New laws, new external and internal risks, and new business operations can all impact businesses’ compliance duties; as a result, businesses must view compliance as an ongoing process rather than a one-time event.
Experts in Compliance
At Corporate Investigation Consulting, our former federal agents are experts in compliance. They understand compliance not only from the private-sector risk management perspective, but also from the government enforcement perspective. These unique insights afford our clients the ability to make informed, strategic, and nimble decisions, and they give our clients’ executives and leaders the confidence they need to focus their time and energy on profit maximization.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
Our Compliance Consulting Services
We provide compliance consulting services in 10 critical areas. Whether your company or practice has a specific compliance focus or needs a comprehensive compliance program overhaul, we can deliver a tailored solution backed by centuries of relevant experience. Our services include:
FDA Compliance Consulting
We assist manufacturers, importers, exporters, distributors, and other clients with all aspects of U.S. Food and Drug Administration (FDA) compliance. Whether your company needs to apply for 510(k) approval or you need to ensure that the products your company sells meet the FDA’s requirements, we can help you put the necessary policies, procedures, and protocols in place.
DEA Compliance Consulting
We assist drug companies, pharmacies, healthcare providers, and other clients with U.S. Drug Enforcement Administration (DEA) compliance. This includes compliance with the DEA’s registration requirements, compliance with the Controlled Substances Act (CSA) and Drug Supply Chain Security Act (DSCSA), compliance with the DEA’s electronic prescription regulations, and other matters.
Healthcare Compliance Consulting
Healthcare entities face myriad compliance duties. From Medicare and Medicaid billing compliance to compliance with all pertinent licensing and registration requirements, healthcare entities must develop and implement comprehensive programs to ensure that they do not garner unwanted scrutiny from state or federal authorities.
DFARS Compliance Consulting
For U.S. Department of Defense (DOD) contractors, Defense Federal Acquisition Regulation Supplement (DFARS) compliance is essential. The DFARS contains requirements above and beyond those in the Federal Acquisition Regulation (FAR), and noncompliance with the DFARS can lead to both loss of bids and loss of government contracts.
Further Information About DFARS Compliance Consulting
HIPAA Compliance Consulting
Even though the Health Insurance Portability and Accountability Act (HIPAA) is now more than 25 years old, it continues to play a central role in healthcare providers’—and many other companies’—business operations. If your company or practice is subject to HIPAA, it must have documented compliance policies and procedures, and it must be able to demonstrate strict adherence to these policies and procedures with substantiating documentation.
Regulatory Compliance Consulting
General and industry-specific regulatory compliance obligations account for the substantial majority of many companies’ and practices’ compliance burdens. From consumer and data security matters to highly nuanced industry standards, we help our clients identify and address all pertinent regulatory requirements. As many regulatory compliance obligations depend on a company’s size or financial resources, assessing the scope of a company’s compliance burden is often the first step toward implementing a sound and cost-effective program.
BSA/AML Compliance Consulting
The Bank Secrecy Act (BSA) and other federal anti-money laundering (AML) laws establish complex and stringent requirements for financial institutions and a broad range of other business entities. Our former federal agents have extensive experience in the area of BSA/AML compliance, and we work with our clients’ key stakeholders to help them establish and maintain compliance.
Export Compliance Consulting
Export compliance is a rapidly evolving area, particularly with regard to the export of digital products and services. We assist traditional exporters, technology companies, defense contractors, and a diverse range of other clients with matters involving U.S. export controls including the Export Administration Regulations (EAR), International Traffic In Arms (ITAR) regulations, and Office of Foreign Asset Control (OFAC) sanctions.
Environmental Compliance Consulting
As environmental concerns continue to garner mainstream attention, legislatures and governmental agencies are prioritizing compliance in this area. This is also an area that has seen significant development in recent years, and that is likely to continue to see significant development for the foreseeable future. We assist clients ranging from oil and gas companies and renewable energy companies to cryptocurrency miners with all aspects of environmental compliance.
Pharma Compliance Consulting
For pharmacies, establishing and maintaining DEA compliance is just one aspect of broader compliance risk management. We help pharmacy owners and pharmacists understand their legal and regulatory obligations, and we help them meet these obligations efficiently and comprehensively through strategic compliance planning. This includes developing tailored policies and procedures, conducting internal training programs, and proactively identifying and addressing compliance failures on an ongoing basis.
Our Approach to Compliance Consulting
Establishing and maintaining compliance requires a multifaceted approach. If a compliance program is not sufficiently comprehensive or is not implemented effectively, it will not function as intended. Compliance failures will happen, and these failures will expose the business to enforcement action (as well as the potential for civil litigation).
When we consult with companies and practices regarding compliance, we rely on our former federal agents’ centuries of combined expertise to provide long-term solutions that eliminate all potential gaps for exposure. Our multifaceted approach involves:
- Comprehensive Compliance Needs Assessment: Based on an intimate understanding of your company or practice, we will conduct a comprehensive compliance needs assessment to determine the scope of your business’s compliance burden.
- Existing Compliance Program Audit: If your company or practice has an existing compliance program, we will audit this program to assess its effectiveness.
- Compliance Strategy Development: With knowledge of your company’s or practice’s needs and existing program (if any), we will develop a strategy that your business can follow to establish and maintain compliance.
- Compliance Program Documentation: Once you approve our strategy, we will provide the necessary compliance program documentation. This documentation will be tailored to your company’s or practice’s size, operations, and needs.
- Implementation: Effective implementation is vital. Through compliance program dissemination and training, we will assist with ensuring that your company or practice is putting its program to use as intended.
- Monitoring: Compliance is not a one-time event. Once we have guided our clients through the implementation phase, we provide ongoing assistance with internal monitoring, auditing, and enforcement.
- External Audit and Investigation Defense Preparedness: Having an effective compliance program will not necessarily prevent an external audit or investigation. But it will provide a means for resolving any external audits or investigations as quickly and favorably as possible. As former federal agents, we understand when, why, and how these inquiries take place, and we know what it takes for businesses to come out unscathed.
FAQs: Developing, Implementing, and Maintaining an Effective Compliance Program
How important is it for companies and practices to have compliance programs?
Having an effective compliance program is extremely important for all types of companies and practices in this day and age. Governmental authorities expect businesses to understand and meet their compliance obligations, and they hold those that fail to do so accountable. Compliance violations can often lead to private civil litigation as well.
Can my company or practice buy an off-the-shelf compliance program?
Buying an off-the-shelf compliance program is inadvisable for a multitude of reasons. Most fundamentally, however, these programs simply don’t work. A compliance program must be tailored to a company’s or practice’s specific operations and risks, and a generic off-the-shelf program will almost certainly leave many gaping holes left to be filled.
Do we need to engage an outside consulting firm for compliance?
We recommend engaging an outside consulting firm for compliance. Developing an effective compliance program requires extensive subject-matter expertise. It also requires familiarity with what really works in compliance program implementation, monitoring, and enforcement. An outside consulting firm staffed with compliance experts will have the knowledge and insights your business needs to avoid costly mistakes.
What are the risks of noncompliance?
The risks of noncompliance can be substantial for companies and practices of all sizes. State and federal authorities can impose civil penalties and refer cases for criminal prosecution when it appears that businesses have intentionally evaded their compliance duties (including turning a “blind eye” to compliance). Class action lawsuits and multi-district litigation (MDL) are common consequences of noncompliance as well.
Contact Us for a Complimentary Initial Consultation
If you would like to know more about our compliance consulting services, we invite you to contact us for a complimentary initial consultation. Please call 866-352-9324 or send us a message online to schedule an appointment today.
Further Areas For Our Compliance Consulting
- Assisting Compliance Officers & General Counsel
- Corporate Compliance Investigations
- Family Investment Offices Business Compliance Audits
- FCPA Compliance
- FCPA Compliance: Conducting Corporate Investigations
- Home Health Agency Compliance Services
- Hospital Compliance Consulting
- Laboratory Compliance Consultant
- Law Firms and Their Clients Compliance Consulting
- Medium to Large Corporations Compliance Consulting
- Pharmacy Compliance Consulting
- Pharmaceutical Manufacture Compliance Consulting
- Private Equity Funds Business Compliance Audits
- SEC Compliance Consultants
- SEC Compliance: Conducting Corporate Investigations